The PATS ( The Preschool ADHD Treatment Study ) trial designed to determine the safety and effectiveness of treating preschoolers who have attention deficit/hyperactivity disorder ( ADHD ) with Methylphenidate ( Ritalin ) has found that overall, low doses of this medication are effective and safe. However, the study found that children this age are more sensitive than older children to the medications side effects and therefore should be closely monitored.
Methylphenidate is the most commonly prescribed medication to treat children diagnosed with ADHD. But its use for children younger than 6 years has not been approved by the FDA ( Food and Drug Administration ).
The 303 preschoolers enrolled in the study ranged in age from 3 to 5 years. The children and their parents participated in a pre-trial, 10-week behavioral therapy and training course. Only those children with the most extreme ADHD symptoms who did not improve after the behavioral therapy course and whose parents agreed to have them treated with medication were included in the medication study.
In the first part of the medication study, the children took a range of doses from a very low amount of 3.75 mg daily of Methylphenidate, administered in three equal doses, up to 22.5 mg/day.
The study then compared the effectiveness of Methylphenidate to placebo. It found that the children taking Methylphenidate had a more marked reduction of their ADHD symptoms compared to children taking a placebo, and that different children responded best to different doses.
The best dose to reduce ADHD symptoms varied substantially among the children, but the average across the whole group was as low as 14 mg per day, said lead author Laurence Greenhill, of Columbia University/New York State Psychiatric Institute. Preschoolers with ADHD may need only a low dose of Methylphenidate initially, but they may need to take a higher dose later on to maintain the drugs effectiveness.
Eleven percent about 1 in 10 children had to drop out of the study as a result of intolerable side effects. For example, while some children lost weight, weight loss of 10 percent or more of the childs baseline weight was considered a severe enough side effect for the investigators to discontinue the medication. Other side effects included insomnia, loss of appetite, mood disturbances such as feeling nervous or worried, and skin-picking behaviors.
Despite concerns that stimulants may increase blood pressure or pulse, any changes seen in the childrens blood pressure or pulse were minimal.
The study has shown that preschoolers with severe ADHD symptoms can benefit from the medication, but doctors should weigh that benefit against the potential for these very young children to be more sensitive than older children to the medications side effects, and monitor use closely, concluded Greenhill.
Source: National Institutes of Health, 2006